ANNUAL REPORT 2012 - TiGenix

Market opportunity of cartilage lesions
According to current medical practice, ICRS
Grade III-IV full thickness cartilage defects
(lesions in which underlying bone is exposed)
larger than 2 cm² are indicated for treatment
with ACI.
The target population with the highest
expected benefit, i.e. patients with an early
onset of symptoms (< 3 years), ICRS grade
III and IV lesions larger than 2 cm 2 located
on the femoral condyle in adults between
18 and 50 years, is estimated to be at least
17,000 per year in Europe, where TiGenix is
currently focusing its commercial efforts on.
The market potential in the Middle East,
where TiGenix has a signed distribution
agreement in place, is estimated at around
8,000 cases per year 5 .
As the Company is currently not focusing
on other markets, it does not have reliable
numbers on the potential global market size.
by patients treated with ChondroCelect
was found to be less fibrous and to display
features indicative of more durable cartilage.
The analysis of the 36-month follow-up data
also demonstrated larger overall clinical
benefit for the ChondroCelect group versus
the microfracture group.
In July 2011, TiGenix published the results
of 5-year follow-up analysis. The results
confirm the durability of the therapeutic
effect of ChondroCelect and demonstrate
the importance of early intervention.
Again, early treatment with ChondroCelect
resulted in a superior clinical benefit over
microfracture and a lower failure rate 6 .
The pivotal TIGACT01 trial data have been
complemented by supplementary information
from an open label trial and other clinical
programs, and in total, circa 850 patients have
been treated with ChondroCelect to date.
6.4.4. Regulatory affairs
The list price for ChondroCelect is EUR 19,837
or GBP 18,301 in the UK.
6.4.3. Clinical validation
The efficacy of ChondroCelect was
evaluated in a Phase III, multicenter,
prospective, randomized controlled trial, the
TIGACT01-study, comparing ChondroCelect
with microfracture in the repair of single
symptomatic cartilage lesions between
1 and 5 cm² on the femoral condyles of the
knee in patients aged 18 to 50 years.
TiGenix is the first company to have obtained
central regulatory approval for a cellbased
medicinal product in Europe, and
ChondroCelect is the first approved product
under the new ATMP regulatory framework
for innovative cell-based, tissue-engineered,
and gene therapy medicines.
The marketing authorisation for
ChondroCelect includes certain follow-up
measures (“FUMs”), the scope and practical
approach of which are currently being
discussed with EMA.
At one year following treatment,
ChondroCelect formed regenerated tissue
that was superior to tissue formed following
microfracture. The repair tissue formed
54 TiGenix I annual report 2012
5
2005 Healthpoint Capital Orthopedic Market Report;
Millennium Research Group, 2008; MARKETSTRAT ® INC.
2008; Curl et al. 1997; Aroen et al. 2004; K. Hjelle et al. 2002;
Widuchowski et al. 2008; Kim S. et al. 2011; and TiGenix
estimates
6
Vanlauwe J, Saris DB, Victor J, Almqvist KF, Bellemans J,
Luyten FP. Five-year outcome of characterized chondrocyte
implantation versus microfracture for symptomatic cartilage
defects of the knee : early treatment matters. Am J Sports
Med. 2011 : 39(12) :2566-74